Gastroesophageal reflux disease (GERD) or persistent heartburn is caused by an improper relaxation of the lower esophageal sphincter (LES) that allows the frequent regurgitation of acidic stomach contents into the esophagus. If left untreated, chronic reflux may cause esophageal stricture, bleeding ulcers, perforation, and scarring. Continued reflux may cause changes in the cells that make up the esophagus, which can in turn lead to cancer. The current mode of treatment is primarily pharmacological, starting with antacids and progressing to proton pump inhibitors (PPIs). The pharmacological treatment ends with double and triple dosing of PPIs. At the point that the patient is not responding to PPIs, a surgical procedure to tighten the LES and make it less compliable is often recommended.
One procedure to tighten the LES involves wrapping a fundus of the stomach around the lower end of the esophagus and fastening it in place. This was traditionally accomplished by open surgery using sutures to secure the plicated fundus of the stomach around the esophagus without penetrating the stomach. More recently, laparoscopic surgery has become standard, and in some laparoscopic procedures surgical fasteners are used with an endoscopic applicator. Several different fastener designs have been developed.
Some of these designs include an applier with a two piece fastener. A male piece of the fastener includes several straight elongate needles extending perpendicularly outward from a base and generally parallel to each other. A female piece of the fastener includes a receiver element having openings positioned for receiving the needles of the male piece and a mating element for holding the needles in place once received in the openings. In use, tissue is gathered, and the needles of the male piece are pushed through the gathered tissue and into the openings of the female piece to hold the tissue fastener in place. This design works fine for a specific range of tissue thicknesses, however, if tissue outside this range is encountered there will be too little compression (thin tissue) to promote serosa to serosa healing, or too much compression (thick tissue) resulting in tissue necrosis. In addition, the needles are exposed when the applier jaws are open, increasing the risk of collateral tissue damage during the procedure.
Thus, there remains a need for an improved surgical fastener that overcomes some of the aforementioned drawbacks.